EUCTR2007-001840-33-IT进行中（未招募）不适用
Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study)
BOEHRINGER ING.0 个研究点目标入组 6,800 人开始时间: 2008年3月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1: Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 < 70 percent of predicted normal and FEV1 < 70 percent of FVC postbronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 μg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC [R94-1408]. For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres))- 0.025 x age (years) - 2.60
- •All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
- •Male or female patients 40 years of age or older.
- •Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or steroids and/or hospitalisation.
- •Patients must be current or ex-smokers with a smoking history of > 10 pack-years. (Patients who have never smoked cigarettes must be excluded.) Pack Years = (Number of cigarettes/day)/20 x years of smoking
- •Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
- •Patients must be able to inhale medication in a competent manner from the HandiHaler (Appendix 10.1) and a metered dose inhaler (MDI) (Appendix 10.2).
- •Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
- •Patients with a diagnosis of asthma. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
- •Patients with known active tuberculosis.
- •Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
研究者
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Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomized, double-blind, double-dummy, parallel group, one year study)pulmonary disease10046304dyspnoeNL-OMON31594Boehringer Ingelheim64
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Effect of inhalation of tiotropium once daily 18 mcg versus salmeteroltwice daily 50 mcg on time to first exacerbation in COPD patients (arandomised, double-blind, double-dummy, parallel group, one-yearstudy). - POETEUCTR2007-001840-33-FRBoehringer Ingelheim Pharma GmbH & Co. KG6,800
进行中（未招募）
不适用
Effect of inhalation of tiotropium once daily 18 mcg versus salmeteroltwice daily 50 mcg on time to first exacerbation in COPD patients (arandomised, double-blind, double-dummy, parallel group, one-yearstudy). - POETchronic obstructive pulmonary disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2007-001840-33-HUBoehringer Ingelheim Pharma GmbH & Co. KG7,350
进行中（未招募）
不适用
Effect of inhalation of tiotropium once daily 18 mcg versus salmeteroltwice daily 50 mcg on time to first exacerbation in COPD patients (arandomised, double-blind, double-dummy, parallel group, one-yearstudy). - POETEUCTR2007-001840-33-BGBoehringer Ingelheim Pharma GmbH & Co. KG7,350
进行中（未招募）
1 期
Effect of inhalation of tiotropium once daily 18 mcg versus salmeteroltwice daily 50 mcg on time to first exacerbation in COPD patients (arandomised, double-blind, double-dummy, parallel group, one-yearstudy).Efecto de la inhalación de 18 microgramos de tiotropio una vez al día frente a 50 microgramos de salmeterol dos veces al día sobre el tiempo hasta la primera exacerbación en pacientes con EPOC (estudio de un año de duración, aleatorizado, en doble ciego, con doble simulación y de grupos paralelos). - POETEUCTR2007-001840-33-ESBoehringer Ingelheim Pharma GmbH & Co. KG6,800